Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 3,000 participants will be enrolled, stratified by age into two groups: 600 participants aged 10-17 years and 2,400 participants aged 18-60 years. Within each age group, participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five vaccination schedule groups: Essen Control Group (Group A), Essen Experimental Group (Group B), Zagreb Experimental Group (Group C), Simplified Four-Dose Group 1 (Group D), and Simplified Four-Dose Group 2 (Group E).
Among participants in the four experimental groups-Essen Experimental Group, Zagreb Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2-stratified block randomization will be applied. Within each age group and each vaccination schedule group, participants will be further randomized in a 1:1:1 ratio into three subgroups: those receiving a booster dose at Day 90 after completion of the primary immunization, those receiving a booster dose at Day 180, and those undergoing assessment of immune persistence at Day 360 after completion of the primary immunization.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essen Control Group | Active Comparator |
| |
| Essen Experimental Group | Experimental |
| |
| Zagreb Experimental Group | Experimental |
| |
| Simplified Four-Dose Group 1 | Experimental |
| |
| Simplified Four-Dose Group 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried | Biological | The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose. | Day 14 after the first dose. | |
| Seroconversion rate of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose. | Day 14 after the last dose. | |
| Incidence of adverse events within different timeframes (30 minutes, 0-7 days, 0-30 days) after each vaccine dose. | Within 30 minutes, 0-7 days, and 0-30 days after each dose | |
| All serious adverse events (SAEs) occurring from the first dose of primary immunization to 6 months after completion of the primary immunization. | From the first dose of primary immunization to 6 months after completion |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose. | Day 14 after the last dose | |
| Comparison of seroconversion rates and GMCs among baseline seronegative participants in the Essen Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2 at Days 28 and 42 after the first dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rate and GMC of rabies virus neutralizing antibodies in a subset of participants at 90 days, 180 days, and 360 days after completion of the primary immunization. | 90, 180, and 360 days post-primary immunization | |
| Seropositivity rate and GMC in a subset of participants at 14, 42, 90, and 180 days after the first dose of re-exposure immunization. |
Inclusion Criteria:
Exclusion Criteria:
a Exclusion criteria for the first dose:
b Exclusion criteria for subsequent doses:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qichun County Center for Disease Control and Prevention | Huanggang | Hubei | China | |||
| Yunyang District Center for Disease Control and Prevention |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried | Biological | The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. Two doses will be administered on Day 0, followed by one dose each on Days 7 and 21, for a total of 4 doses. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase. |
|
| Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried | Biological | The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7 and 14. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase. |
|
| Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried | Biological | The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase. |
|
| Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried | Biological | The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28. |
|
| Days 28 and 42 after the first dose |
| Comparison of seroconversion rates and GMCs in baseline seronegative participants between the Essen Experimental Group and the Zagreb Experimental Group at Day 7 after the first dose. | Day 7 after the first dose |
| 14, 42, 90, and 180 days after re-exposure immunization |
| Shiyan |
| Hubei |
| China |
| Zhushan county Center for Disease control and Prevention | Shiyan | Hubei | China |
| Gucheng county Center for Disease control and Prevention | Xiangyang | Hubei | China |
| Xiangzhou District Center for Disease Control and Prevention | Xiangyang | Hubei | China |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided